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Implantation with HistopathologyTests

Implantation with HistopathologyTests

The Implantation with Histopathology test determines the local pathological effects of an implanted device. This test allows manufacturers to assess the impact the implanted material has on surrounding tissue and major body organs. Histopathology is necessary to meet the ISO requirements. Implantation tests comply with ISO 10993-6.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

  • ISO 10993-6

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
SCX610 Implant Study: ISO 1 week, Surgical implant w/ histo, each Add
SCX611 Implant Study (GLP): ISO 1 week, Surgical implant w/ histo, each Add
SCX615 Implant Study: ISO 1 week, Subcutaneous w/ histo, each Add
SCX616 Implant Study (GLP): ISO 1 week, Subcutaneous w/ histo, each Add
SCX620 Implant Study: ISO 2 week, Surgical implant w/ histo, each Add
SCX621 Implant Study (GLP): ISO 2 week, Surgical implant w/ histo, each Add
SCX625 Implant Study: ISO 2 week, Subcutaneous w/ histo, each Add
SCX626 Implant Study (GLP): ISO 2 week, Subcutaneous w/ histo, each Add
SCX630 Implant Study: ISO 4 week, Surgical implant w/ histo, each Add
SCX631 Implant Study (GLP): ISO 4 week, Surgical implant w/ histo, each Add
SCX635 Implant Study: ISO 4 week, Subcutaneous w/ histo, each Add
SCX636 Implant Study (GLP): ISO 4 week, Subcutaneous w/ histo, each Add
SCX640 Implant Study: ISO 8 week, Surgical implant w/ histo, each Add
SCX641 Implant Study (GLP): ISO 8 week, Surgical implant w/ histo, each Add
SCX645 Implant Study: ISO 8 week, Subcutaneous w/ histo, each Add
SCX646 Implant Study (GLP): ISO 8 week, Subcutaneous w/ histo, each Add
SCX650 Implant Study: ISO 13 week, Surgical implant w/ histo, each Add
SCX651 Implant Study (GLP): ISO 13 week, Surgical implant w/ histo, each Add
SCX652 Implant Study (GLP): ISO 26 week, Surgical implant w/ histo (3 rabbits), each Add
SCX653 Implant Study (GLP): ISO 26 week, Surgical implant w/ histo (4 rabbits), each Add
SCX655 Implant Study: ISO 13 week, Subcutaneous w/ histo, each Add
SCX656 Implant Study (GLP): ISO 13 week, Subcutaneous w/ histo, each Add
SCX657 Implant Study (GLP): ISO 26 week, Subcutaneous w/ histo (3 rabbits), each Add
SCX658 Implant Study (GLP): ISO 26 week, Subcutaneous w/ histo (4 rabbits), each Add
SCX610 - Implant Study: ISO 1 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX611 - Implant Study (GLP): ISO 1 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX615 - Implant Study: ISO 1 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX616 - Implant Study (GLP): ISO 1 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX620 - Implant Study: ISO 2 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX621 - Implant Study (GLP): ISO 2 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX625 - Implant Study: ISO 2 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX626 - Implant Study (GLP): ISO 2 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX630 - Implant Study: ISO 4 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX631 - Implant Study (GLP): ISO 4 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX635 - Implant Study: ISO 4 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX636 - Implant Study (GLP): ISO 4 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX640 - Implant Study: ISO 8 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX641 - Implant Study (GLP): ISO 8 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX645 - Implant Study: ISO 8 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX646 - Implant Study (GLP): ISO 8 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX650 - Implant Study: ISO 13 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX651 - Implant Study (GLP): ISO 13 week, Surgical implant w/ histo, each
Standard TAT not available for this product
SCX652 - Implant Study (GLP): ISO 26 week, Surgical implant w/ histo (3 rabbits), each
Standard TAT not available for this product
SCX653 - Implant Study (GLP): ISO 26 week, Surgical implant w/ histo (4 rabbits), each
Standard TAT not available for this product
SCX655 - Implant Study: ISO 13 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX656 - Implant Study (GLP): ISO 13 week, Subcutaneous w/ histo, each
Standard TAT not available for this product
SCX657 - Implant Study (GLP): ISO 26 week, Subcutaneous w/ histo (3 rabbits), each
Standard TAT not available for this product
SCX658 - Implant Study (GLP): ISO 26 week, Subcutaneous w/ histo (4 rabbits), each
Standard TAT not available for this product

Sample Specifications

SCX610: Turn Around Time is 65 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX611: Turn Around Time is 65 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX615: Turn Around Time is 65 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX616: Turn Around Time is 65 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX620: Turn Around Time is 56 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX621: Turn Around Time is 56 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX625: Turn Around Time is 56 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX626: Turn Around Time is 56 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX630: Turn Around Time is 70 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX631: Turn Around Time is 70 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX635: Turn Around Time is 70 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX636: Turn Around Time is 70 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX640: Turn Around Time is 105 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX641: Turn Around Time is 105 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX645: Turn Around Time is 105 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX646: Turn Around Time is 105 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX650: Turn Around Time is 133 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX651: Turn Around Time is 133 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX652: Turn Around Time is 230 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX653: Turn Around Time is 230 days from PDS approval. 20, 1 x 1 x 10 mm strips.
SCX655: Turn Around Time is 133 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX656: Turn Around Time is 133 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX657: Turn Around Time is 230 days from PDS approval. 14, 1 x 1 x 10 mm strips.
SCX658: Turn Around Time is 230 days from PDS approval. 20, 1 x 1 x 10 mm strips.

Study Outline

In the Implantation with Histopathology test, representative portions of the device, or the entire device, are implanted in the paravertebral muscles of live rabbits for a predetermined exposure period. Gross necropsy observations will be made and implant sites harvested and fixed. Microscopic evaluation will include: cell type, cell distribution, fibroplasia and neovascularization.